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|CEDARS-SINAI MEDICAL CENTER||8700 BEVERLY BLVD LOS ANGELES, CA 90048||July 21, 2015|
|VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING||Tag No: A0144|
|Based on observation, interview and record review, the facility failed to ensure the right of Patient 1 to receive surgical care in a safe setting by a qualified personnel. During Patient 1's upper gastro-intestinal (GI)endoscopy (a direct visualization of the digestive tract for diagnostic evaluation and screening, Gastrointestinal Endoscopy, 2009), Staff 2 was observed assisting Physician 1 to perform a biopsy of tissue by tightening the snare in order to cinch it tight around the base of the elevated tissue. The snare is a wire loop and part of the device used for the endoscopy procedure. Staff 2, is a Specialty Technician, Endoscopy III, and there was no documented evidence of his competency to perform the biopsy of stomach tissue in concert with a physician, who was reviewed and approved by the medical staff and governing body of the hospital.
This failure exposed the patient to harm or the risk of harm in being subjected to surgical procedure by the staff that had not been privileged to perform this surgical procedure.
On July 21, 2015 at 12:30 p.m., during a follow up visit, a tracer observation was conducted of Patient 1's procedure, endogastrodudoudenoscopy (looking inside the digestive tract). Staff 2 was observed assisting Physician 1 performing a biopsy of tissue during an upper GI endoscopy. The procedure involved closing of a wire snare, a biopsy loop, around a segment of stomach lining tissue identified by Physician 1. Immediately preceding this step, a small amount of saline solution was injected at the base of the identified tissue by means of a long needle instrument. The purpose was to elevate a suspicious area of tissue from the surrounding gastric, mucosal tissue facilitating its being removed. Physician 1 positioned a wire, snare biopsy loop, around the protrusion of tissue. Upon the direction of Physician 1, Staff 2 tightened the snare in order to cinch it tight around the base of the elevated tissue. Next, Physician 1 applied a cutting, electric current to the snare and twisted it in such a manner as to remove the already-cut biopsied tissue. Finally, a small fabric, meshed bag-like device was grasped by the endoscope and inserted into the abdomen. The excised tissue was manipulated into the bag by Physician 1 and withdrawn from the abdominal cavity through the incision in which the endoscope had been inserted.
The closing of the snare, wire biopsy loop constituted a portion of the severing of the tissue specimen from its location in the stomach lining and resulted from the action of Staff 2. When interviewed, Physician 1 agreed the removal of tissue constituted a biopsy and further acknowledged Staff 2 did not have medical staff privileges to do so.
On July 21, 2015 at 2:00 p.m., a review of the personnel file of Staff 2 indicated he was functioning outside of his scope of practice when he participated in the biopsy that was taken in the course of Patient 1's surgical care. There was no evidence of his competency to perform a surgical procedure; specifically, the biopsy of stomach tissue in concert with a physician, who was reviewed and approved by the medical staff and governing body of the hospital.
Staff 2's personnel file indicated "Cook Duette Multi-Band Mucusectomy (a device used for endoscopic mucosal resection in the gastro-intestinal tract) Competency" dated June 1, 2012. The competency dated June 1, 2012, indicated Staff 2 had completed competency in the use of snare:
"Fully rectracts and extends the snare to confirm smooth operation.
Slides the adjustable marker, located in the handle shaft, to establish a reference point indicating full retraction of the snare into the sheath.
Explains how to use grid on the handle to set up reference point to establish thickness of the tissue being excised during procedure."
There was no documented evidence that Staff 2 had completed this specific competency after June 1, 2012.
Staff 2's Job Summary and "Job Responsibilities" dated June 5, 2015, from the "Job Description/Performance Appraisal," indicated the Specialty Technician is under the supervision of the Registered Nurse, assigned to perform technical duties, and assist with procedures. However, assisting with procedures with specific duties, as well as, the use of snare during an upper gastro-intestinal endoscopy were not specified.